The integration of Artificial Intelligence (AI) in various sectors has been nothing short of transformative, and now, it’s poised to revolutionize the pharmaceutical industry. The U.S. Food and Drug ...

In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an unprecedented role in drug ...

Drug makers now need government approval for any quality changes to medicines. This applies to alterations affecting a drug's ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

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FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

OTTAWA--Canada said Friday it intends to accelerate drug approvals in the country by relying on work done by foreign pharmaceutical regulators. Canada's health department said in a notice that this ...

This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. When Sarepta Therapeutics revealed this month that a ...